MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-15 for IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY L2KUN manufactured by Siemens Medical Diagnostics, Inc..
[979923]
Several discordant immulite 2000 3g allergy specific ige (i3 & ii) results were generated on two patient samples. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant 3g allergy specific ige results.
Patient Sequence No: 1, Text Type: D, B5
[8213204]
Analysis of the instrument and instrument data indicate that the cause for the discordant 3g allergy specific ige results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[6073634]
Several discordant immulite 2000 3g allergy specific ige (i3 & ii) results were generated on two patient samples. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant 3g allergy specific ige results.
Patient Sequence No: 2, Text Type: D, B5
[13518705]
Analysis of the instrument and instrument data indicate that the cause for the discordant 3g allergy specific ige results is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 2017183-2008-00041 |
| MDR Report Key | 1208539 |
| Report Source | 05 |
| Date Received | 2008-10-15 |
| Date of Report | 2008-08-08 |
| Date of Event | 2008-07-30 |
| Date Mfgr Received | 2008-08-08 |
| Date Added to Maude | 2009-06-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 5210 PACIFIC CONCOURSE |
| Manufacturer City | LOS ANGELES CA 900455597 |
| Manufacturer Country | US |
| Manufacturer Postal | 900455597 |
| Manufacturer Phone | 5086608540 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 5700 W. 96TH STREET |
| Manufacturer City | LOS ANGELES CA 90045559 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90045 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY |
| Generic Name | ALLERGY IMMUNOASSAYS |
| Product Code | DHB |
| Date Received | 2008-10-15 |
| Model Number | NA |
| Catalog Number | L2KUN |
| Lot Number | 246 |
| ID Number | NA |
| Device Expiration Date | 2009-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL DIAGNOSTICS, INC. |
| Manufacturer Address | LOS ANGELES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-15 | |
| 2 | 0 | 2008-10-15 |